SMG 1283.4

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE CHIEF SCIENTIST

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF RESEARCH

DIVISION OF BIOCHEMICAL TOXICOLOGY

Effective Date: 07/08/2011

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1. DIVISION OF BIOCHEMICAL TOXICOLOGY (DAECCA)

A. Advises the Deputy Director for Research in the planning and implementation of strategies for achieving annual and long-range plans for research and research support in the area of biochemical toxicology

B. Conducts long-term studies to develop improved methods for evaluating exposure of experimental animals to possible life-shortening carcinogenic toxicants

C. Determines and describes dose-time response relationships for specific chemical toxicants in experimental animals

D. Conducts studies to develop biological and biochemical information, facilitating a better understanding of the mechanisms of toxic responses

E. Innovates, designs, and develops new approaches and procedures that expand pathology capabilities for utilization in the assessment of the toxicity of compounds

F. Operates an instrument laboratory and conducts studies utilizing highly specialized techniques of nuclear magnetic resonance spectrometry

G. Defines biochemical mechanisms involving the relationship of DNA adducts to tumor formation, distribution of activation or detoxification enzymes, and drug-protein adduct identification

H. Develops more sensitive methods of adduct detection, mass spectrometry (MS) and nuclear magnetic resonance (NMR) techniques, and immunochemical detection

I. Provides FDA leadership in the Agency’s participation in the National Toxicology Program (NTP). Plans and implements sub-chronic and chronic toxicological evaluations emphasizing dose response relationships for the NTP, FDA, and various Federal and state agencies

J. Administers and has lead scientific responsibilities for NCTR’s Solid-State Toxicity Program and Biomarkers and Molecular Markers of Cancer Program

K. Directs the Center’s participation in the Interdisciplinary Toxicology (INTOX) Program

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of Health and Human Services, effective July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	07/08/2011	N/a	OO/OM	Secretary of the Department of Health and Human Services